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A Review of the Medical Challenges of Using Direct Oral Anticoagulants in Real-World Practice

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Abstract

Clinical guidelines for management of non-valvular atrial fibrillation or venous thromboembolism currently recommend direct oral anticoagulants as the preferred strategy for antithrombotic treatment. As a result, they are increasingly being used as an alternative to conventional therapy. However, they are unlikely to completely replace conventional approaches, due to a number of existing medical challenges. These challenges relate to the uncertainty of optimal dose regimens and the strategy of using them in specific patient populations with non-valvular atrial fibrillation or venous thromboembolism. The efficacy and safety profile of dabigatran among various regions may differ, depending on regional variations in dosing recommendations. Furthermore, optimal dose regimens may be different between Asian and non-Asian populations. It will be necessary to collect real-world clinical data on the use of edoxaban in patients with non-valvular atrial fibrillation with high-creatinine clearances, to determine the optimal dose required for stroke protection. In addition, the efficacy of combination therapy utilizing direct oral anticoagulants and antiplatelet agents has not yet been established in patients with non-valvular atrial fibrillation with acute coronary syndrome and/or percutaneous coronary intervention with stenting. Low-molecular-weight heparin is, therefore, suggested to be used in preference to vitamin K antagonists or direct oral anticoagulants in current clinical practice guidelines, as indirect comparisons suggests that oral anticoagulants are less effective than low-molecular-weight heparin. Consequently, we need to focus on the outcomes of ongoing studies and review more real-world data in heterogeneous populations to complement clinical data obtained from controlled studies with highly selective populations. Therefore, direct oral anticoagulants should be used with caution based on individual assessments of thromboembolic and bleeding risks as well as other clinical characteristics.

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  1. College of Pharmacy, EwhaWomans University, Seoul, Republic of Korea

    IlYoung Cho MS

  2. Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety, 187, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, 28159, Chungcheongbuk-do, Republic of Korea

    IlYoung Cho MS

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Cho, I. A Review of the Medical Challenges of Using Direct Oral Anticoagulants in Real-World Practice. Ther Innov Regul Sci 54, 793–802 (2020). https://doi.org/10.1007/s43441-019-00001-9

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